Filter, Blood, Dialysis

Device Code: 1901

Product Code(s): FKJ

Device Classification Information

• Device Type ID: 1901
• Device Name: Filter, Blood, Dialysis
• Regulation Description: Hemodialysis System And Accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD); Renal Devices Branch (RNDB)
• Submission Type: 510(k)
• CFR Regulation Number: 876.5820 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: FKJ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: Yes
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 9-89 ISO 8638 Third Edition 2010-07-01
  Cadiovascular Implants And Extracorporeal Blood Circuit For Hemodialyzers, Hemodialfilters, And Hemofilters
• 9-92 ISO 8637 Third Edition 2010-07-01
  Cardiovascular Implants And Extracorporeal Systems - Hemodialyzers, Hemodiafilters, Hemofilters, And Hemoconcentrators [Including: Amendment 1 (2013)]
• 9-118 ISO 8637-1 First Edition 2017-11
  Extracorporeal Systems For Blood Purification -- Part 1: Haemodialysers, Haemodiafilters, Haemofilters And Haemoconcentrators

Total Product Life Cycle

• Device Type ID: 1901
• Device: Filter, Blood, Dialysis
• Product Code: FKJ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Hemodialysis System And Accessories.
• CFR Regulation Number: 876.5820 [🔎]

Device Problems
Filtration Problem	33
Inadequate Ultra Filtration	12
Calibration Problem	5
Device Alarm System	4
Use Of Device Problem	2
Adverse Event Without Identified Device Or Use Problem	1
Device Sensing Problem	1
Display Difficult To Read	1
Device Operational Issue	1
Computer Software Problem	1
Temperature Problem	1
Insufficient Information	1
Total Device Problems	63

TPLC Last Update: 2019-04-02 20:01:40